New HIV drug approved

August 13, 2013

FDA this week approved integrase strand transfer inhibitor dolutegravir (Tivicay, ViiV Healthcare , GlaxoSmithKline) to treat HIV-1 infection.

FDA this week approved integrase strand transfer inhibitor dolutegravir (Tivicay, ViiV Healthcare , GlaxoSmithKline) to treat HIV-1 infection.

Dolutegravir is approved for use in a broad population of HIV-infected patients. It can be used to treat HIV-infected adults who have never taken HIV therapy (treatment-naïve) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors. It also is approved for children aged 12 years and older weighing at least 40 kilograms (kg) who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors.

Dolutegravir interferes with 1 of the enzymes necessary for HIV to multiply and is a tablet taken daily in combination with other antiretroviral drugs.

“The approval of [dolutegravir] offers the opportunity for a broad spectrum of infected individuals to be treated, and in addition another available line of therapy on market to combat help in the treatment of this virus,” said Formulary advisor Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, Webster, Texas.

Dolutegravir’s safety and efficacy in adults was evaluated in 2,539 participants enrolled in 4 clinical trials. Depending on the trial, participants were randomly assigned to receive dolutegravir or raltegravir (Isentress, Merck), each in combination with other antiretroviral drugs, or efavirenz, emtricitabine and tenofovir (Atripla, Bristol-Myers Squibb). Results showed dolutegravir-containing regimens were effective in reducing viral loads.

A fifth trial established the pharmacokinetics, safety, and activity of dolutegravir as part of treatment regimens for HIV-infected children aged 12 years and older weighing at least 40 kg who have not previously taken integrase strand transfer inhibitors.

Insomnia and headache were common side effects observed during clinical studies. Serious side effects include hypersensitivity reactions and abnormal liver function in participants co-infected with hepatitis B and/or C. The dolutegravir label informs healthcare professionals on how to monitor patients for the serious side effects.

About 50,000 Americans become infected with HIV each year and about 15,500 died from the disease in 2010, according to the Centers for Disease Control and Prevention.